NDC 10122-820

BETHKIS

Tobramycin

BETHKIS is a Respiratory (inhalation) Solution in the Human Prescription Drug category. It is labeled and distributed by Chiesi Usa, Inc.. The primary component is Tobramycin.

• Product ID: 10122-820_2783f6ec-3fb8-4191-8870-a93e1f528679
• NDC: 10122-820
• Product Type: Human Prescription Drug
• Proprietary Name: BETHKIS
• Generic Name: Tobramycin
• Dosage Form: Solution
• Route of Administration: RESPIRATORY (INHALATION)
• Marketing Start Date: 2013-04-15
• Marketing Category: NDA / NDA
• Application Number: NDA201820
• Labeler Name: Chiesi USA, Inc.
• Substance Name: TOBRAMYCIN
• Active Ingredient Strength: 300 mg/4mL
• Pharm Classes: Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 10122-820-28

7 POUCH in 1 CARTON (10122-820-28) > 4 AMPULE in 1 POUCH > 4 mL in 1 AMPULE

• Marketing Start Date: 2013-04-15
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 10122-820-04 [10122082004]

BETHKIS SOLUTION

• Marketing Category: NDA
• Application Number: NDA201820
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2013-04-15
• Marketing End Date: 2014-03-27

NDC 10122-820-28 [10122082028]

BETHKIS SOLUTION

• Marketing Category: NDA
• Application Number: NDA201820
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2013-04-15

NDC 10122-820-56 [10122082056]

BETHKIS SOLUTION

• Marketing Category: NDA
• Application Number: NDA201820
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2013-04-15

Drug Details

Active Ingredients

Ingredient	Strength
TOBRAMYCIN	300 mg/4mL

OpenFDA Data

• SPL SET ID: 1cd3d47b-025f-4705-9daf-cf07725ec223
• Manufacturer:
  • Chiesi USA, Inc.
• UNII:
  • VZ8RRZ51VK
• RxNorm Concept Unique ID - RxCUI:
  • 1314763
  • 1314768

Pharmacological Class

• Aminoglycoside Antibacterial [EPC]
• Aminoglycosides [CS]

NDC Crossover Matching brand name "BETHKIS" or generic name "Tobramycin"

NDC	Brand Name	Generic Name
10122-820	BETHKIS	tobramycin
0078-0494	TOBI	Tobramycin
0078-0630	TOBI Podhaler	Tobramycin
0093-3750	Tobramycin	Tobramycin
0093-4085	Tobramycin	Tobramycin
0404-7196	Tobramycin	Tobramycin
0409-3578	TOBRAMYCIN	TOBRAMYCIN
0703-9402	Tobramycin	Tobramycin
0781-7171	Tobramycin	Tobramycin
10544-883	Tobramycin	Tobramycin
13985-604	Tobramycin	Tobramycin
13985-743	Tobramycin	Tobramycin
17478-290	Tobramycin	Tobramycin
17478-340	Tobramycin	Tobramycin
0065-0643	Tobrex	tobramycin
0065-0644	TOBREX	tobramycin
0078-0813	TOBREX	tobramycin